Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Baltimore VA Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan B. Kesmodel, MD, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01954706
First received: September 27, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

Hormone receptor-positive tumors are the most common breast cancers in postmenopausal women, and drug therapies, which block the production or effects of estrogen, are the mainstay of treatment in these patients. Due to their effectiveness in postmenopausal women, aromatase inhibitors (AIs) are the standard of care for long-term estrogen suppression in these patients. Estrogen deficiency, however, results in multiple side effects. Some of the most common side effects in women taking AIs are joint and muscle aches, which promote physical deconditioning. Because of the long term use of AIs in postmenopausal breast cancer patients and the improvements in cancer-related outcomes that are observed with their use, identifying methods to reduce these side effects to maintain adherence to treatment is important. Exercise interventions in breast cancer patients also improve quality of life and reduce fatigue. Understanding the role of exercise in AI side effect prevention will allow us to translate these findings into therapy guidelines.


Condition Intervention
Breast Cancer
Sarcopenia
Other: Structured Exercise
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Trial of Aerobic and Resistance Exercise Training for the Primary Prevention of Musculoskeletal Side Effects From Aromatase Inhibitors in Postmenopausal Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:
  • Fatigue (VAS, Piper Fatigue) and muscle performance (muscle strength, endurance, and function) Fatigue and muscle performance [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Fatigue (questionnaires) and muscle performance (muscle strength, endurance, and function)

  • Fatigue (VAS, Piper Fatigue) and muscle performance (muscle strength, endurance, and function) Fatigue and Muscle Performance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Fatigue (questionnaire) and muscle performance (muscle strength, endurance, and function)

  • Musculoskeletal symptoms (VASpain, HAQ-DI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Musculoskeletal symptoms (VASpain, HAQ-DI)

  • Musculoskeletal symptoms (VASpain, HAQ-DI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Musculoskeletal symptoms (VASpain, HAQ-DI)


Secondary Outcome Measures:
  • Glucose Tolerance and Inflammation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Glucose Tolerance and Inflammation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Structured Exercise Other: Structured Exercise
Structured and supervised aerobic and resistance training 2 times per week
Active Comparator: Usual Care Other: Usual Care
Subjects will be counseled on American Cancer Society and American College of Sports Medicine physical activity and nutritional guidelines at the initiation of the study. Study participants will be contacted by a physician or nurse on weeks 2, 6, 10, and 14 to provide support and encouragement to patients.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least mild fatigue in 2 of the 4 areas of the Piper Fatigue Scale (score ≥ 1-3)
  • Completion of standard surgery +/- chemotherapy for breast cancer (may undergo radiation therapy during study)
  • 25-OH vitamin D > 20 ng/ml
  • Histological evidence of stage I-III hormone receptor-positive breast cancer
  • Body Mass Index >/=18 and <50 kg/m2
  • 40-80 years of age
  • Non-smoking (non smoking for at least 12 months: cigarettes, cigars, pipes
  • Menopause over one year (absence of menses for 12 months or greater)
  • Sedentary (exercise no >60 min 2 times/week)

Exclusion Criteria:

  • Taking oral steroids, warfarin, or other medications interfering with fat metabolism that may not be safely discontinued temporarily for specific produces (i.e. for 72 hours prior)
  • Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension (systolic blood pressure over 180 mm HG)unless medically stabilized
  • Participant is, in the opinion of the investigator, unable to adhere to the study protocol due to medical or orthopedic conditions that limit ability to exercise or travel to the Baltimore VA for protocol procedures
  • Chronic pulmonary disease (on supplemental O2)
  • Abnormal renal function (BUN above 40 mg/dl, Cr above 1.3 mg/dl, CrCl<60mg/dl)
  • Unstable lymphedema
  • Evidence of cancer metastases or recurrence
  • Anemia HCT below 30 mg/dl, platelets below 80,000/cm3
  • Type 1 diabetes; insulin treatment for diabetes, poorly controlled diabetes, HgA1c>10%
  • Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120 mm HG, or other contraindications to exercise) confirmed with further diagnostic evaluations.
  • Abnormal liver function
  • Untreated dyslipidemia with National Cholesterol ATPIII 10 year cardiac risk score greater than 10% (www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm)
  • Metal implants or devices (i.e. pacemaker) if undergoing CT scan
  • History of seizures or taking anti-seizure or anti convulsion medication
  • Allergic to lidocaine
  • Mini-mental state examination below 24, dementia, or unstable clinical depression by exam
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954706

Contacts
Contact: Monica C Serra, PhD 410 605 7000 ext 4199 monica.serra@va.gov
Contact: Lynda Robey, MS 410 605 7000 ext 5446 lynda.robey@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Monica C Serra, PhD    410-605-7000 ext 4199    monica.serra@va.gov   
Principal Investigator: Susan B Kesmodel, MD         
Sub-Investigator: Monica C Serra, PhD         
Sponsors and Collaborators
Baltimore VA Medical Center
  More Information

No publications provided

Responsible Party: Susan B. Kesmodel, MD, Assistant Professor of Surgery, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT01954706     History of Changes
Other Study ID Numbers: HP-00056384, RFA-DK-04-016
Study First Received: September 27, 2013
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Sarcopenia
Skin Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014